SEREVENT EVOHALER 25 MICROGRAMS PRESSURISED INHALATION SUSPENSION

Transcript

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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SEREVENT EVOHALER 25 micrograms PRESSURISED INHALATION, SUSPENSION
(salmeterol xinafoate)
This medicine is known as the above name but will be referred to as Serevent Evohaler throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.
In this leaflet:
1. What Serevent Evohaler is and what it is used for
2. What you need to know before you use Serevent Evohaler
3. How to use Serevent Evohaler
4. Possible side effects
5. How to store Serevent Evohaler
6. Contents of the pack and other information
1. WHAT SEREVENT EVOHALER IS AND WHAT IT IS USED FOR
• Serevent Evohaler contains the medicine salmeterol. It is a ‘long-acting bronchodilator’. It helps the airways in
the lungs to stay open. This makes it easier for air to get in and out. The effects are usually felt within 10 to 20
minutes and last for 12 hours or more.
• The doctor has prescribed it to help prevent breathing problems. These could be caused by asthma. Taking
Serevent Evohaler regularly will help prevent asthma attacks. This also includes asthma brought on by exercise
or at night.
• Taking Serevent Evohaler regularly will also help prevent breathing problems caused by other chest illnesses
such as Chronic Obstructive Pulmonary Disease (COPD).
• Serevent Evohaler helps to stop breathlessness and wheezing coming on. It does not work once you are
breathless or wheezy. If that happens, you need to use a fast-acting ‘reliever’ medicine, such as salbutamol.
• Serevent Evohaler is supplied to you in an inhaler. You breathe the medicine directly into your lungs.
• Serevent Evohaler contains norflurane. This is less harmful to the environment than older inhalers. Older
inhalers may taste differently to Serevent Evohaler. This will make no difference to how your medicine works.
If you are being treated for asthma, you should always be given both a Serevent Evohaler and a steroid
inhaler to use together.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SEREVENT EVOHALER
Do not take Serevent Evohaler if:
you are allergic (hypersensitive) to salmeterol or to the other ingredient norflurane (HFA 134a).
Take special care with Serevent Evohaler
• If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more
wheezy, your chest feels tight more often or you may need to use more of your fast-acting ‘reliever’ medicine. If
any of these happen, do not increase your number of puffs of Serevent Evohaler. Your chest condition may be
getting worse and you could become seriously ill. See your doctor as you may need a change in asthma
treatment.
• Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of
Serevent Evohaler.
• If you have been prescribed Serevent Evohaler for your asthma, continue to use any other asthma medication
you are already taking. These could include a steroid inhaler or steroid tablets. Continue taking the same doses
as before, unless your doctor tells you otherwise. Do this even if you feel much better. Do not stop taking your
steroid inhaler (or any steroid tablets) when you start using Serevent Evohaler.
• Your doctor may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus
(Serevent Evohaler may increase your blood sugar) or heart disease, including an irregular or fast heartbeat.
Other medicines and Serevent
• Tell your doctor if you are taking or have recently taken any other medicines. This includes those for asthma or
any other medicines obtained without a prescription. This is because Serevent Evohaler may not be suitable to
be taken with other medicines.
• Inform your doctor before using Serevent Evohaler if you are currently being treated for any fungal infections
with medicines containing ketoconazole or itraconazole, or if you are being treated for HIV with ritonavir. These
medicines may increase the risk of you experiencing side effects with Serevent Evohaler, including irregular
heartbeats, or may make side effects worse.
• Beta-Blockers should be avoided when taking Serevent Evohaler, unless your doctor tells you to take them.
Beta-blockers, including atenolol, propranolol and sotalol, are mostly used for high blood pressure or other heart
conditions. Tell your doctor if you are taking beta-blockers or have recently been prescribed beta-blockers as
they may reduce or abolish the effects of salmeterol.
• Serevent Evohaler can reduce the amount of potassium in your blood. If this happens you may notice an
uneven heartbeat, muscle weakness or cramp. This is more likely to happen if you take Serevent Evohaler with
some medicines used to treat high blood pressure (diuretics) and other medicines used to treat breathing
problems such as theophylline or steroids. Your doctor may ask for you to have blood tests to check the amount
of potassium in your blood. If you have any concerns discuss them with your doctor.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
The possible side effects associated with Serevent Evohaler are unlikely to affect your ability to drive or use
machines.
3. HOW TO USE SEREVENT EVOHALER
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist
if you are not sure.
• If you are being treated for asthma, you should always be given both a Serevent Evohaler and a steroid
inhaler to use together.
• Use Serevent Evohaler every day, until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
Serevent Evohaler is for inhalation by mouth only.
Adults and adolescents aged 12 years and older with Asthma
• The usual starting dose is 2 puffs twice a day.
• For people with more severe asthma, your doctor may increase your dose to 4 puffs twice a day.
Children with Asthma
• In children aged 4 to 12 the usual dose is 2 puffs twice a day.
• Serevent Evohaler is not recommended for use in children below 4 years of age.
Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis and emphysema
• The usual starting dose is 2 puffs twice a day.
• Not applicable for children and adolescents.
Instructions for use
Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from
time to time. Not using the inhaler properly or as prescribed, may mean that the medicine will not help your asthma
or COPD as it should.
The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.
Testing your inhaler
1 When using your inhaler for the first time, test that it is working. Remove the
mouthpiece cover by gently squeezing the sides with your thumb and
forefinger and pull apart.
2 To make sure that it works, shake it well, point the mouthpiece away from
you and press the canister to release a puff into the air. If you have not used
the inhaler for a week or more, release one puff of medicine into the air.

Using your inhaler
It is important to start to breathe in as slowly as possible just before using your inhaler.
1 Stand or sit upright when using your inhaler.
2 Remove the mouthpiece cover (as shown in the first
picture). Check inside and outside to make sure that the
mouthpiece is clean and free of objects.
3 Shake the inhaler 4 or 5 times to ensure that any loose
objects are removed and that the contents of the inhaler are
evenly mixed.
4 Hold the inhaler upright with your thumb on the base, below
the mouthpiece. Breathe out as far as is comfortable.
5 Place the mouthpiece in your mouth between your teeth.
Close your lips around it. Do not bite.
6 Breathe in through your mouth. Just after starting to
breathe in, press down on the top of the canister to release a
puff of medicine. Do this while still breathing in steadily and
deeply.
7. Hold your breath, take the inhaler from your mouth and your finger from the top of
the inhaler. Continue holding your breath for a few seconds, or as long as is
comfortable.
8 Wait about half a minute between taking each puff of medicine and then repeat steps 3
to 7.
9 After use always replace the mouthpiece cover immediately to keep out dust.
Replace the cover by firmly pushing and snapping the cap into position.
Practice in front of a mirror for the first few times. If you see a ‘mist’ coming from the top
of your inhaler or the sides of your mouth you should start again
If you or your child find it difficult to use Serevent Evohaler, it may be used with other devices to make its use
easier e.g. a HaleraidTM or VolumaticTM spacer device. Serevent Evohaler is also available in an alternative device.
Talk to your doctor, nurse or pharmacist for further advice.
Cleaning your inhaler
To stop your inhaler blocking up, it is important to clean it at least once a week.
To clean your inhaler:
• Remove the mouthpiece cover.
• Do not remove the metal canister from the plastic casing at any time.
• Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover.
Do not put the metal canister in water.
If you use more Serevent Evohaler than you should
It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to
your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky and/or
dizzy. You may also have a headache, muscle weakness and aching joints.
If you forget to use Serevent Evohaler
Do not take a double dose to make up for a missed dose. Just take your next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chances
of side effects, your doctor will prescribe the lowest dose of Serevent Evohaler to control your asthma or COPD.
These are the side effects reported by people taking Serevent Evohaler.
Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent Evohaler. You
may be very wheezy and cough. You may also notice itching and swelling (usually of the face, lips, tongue or
throat). If you get these effects or they happen suddenly after using Serevent Evohaler, tell your doctor straight
away. Allergic reactions to Serevent Evohaler are very rare (they affect less than 1 person in 10,000).
Other side effects are listed below:
Common (affects less than 1 person in 10):
• Muscle cramps
• Feeling shaky; fast or uneven heartbeat (palpitations), headache, shaking hands (tremor). Tremors are more
likely if you are taking more than two puffs twice daily. These side effects do not last long and happen less as
treatment with Serevent Evohaler continues.
Uncommon (affects less than 1 person in 100):
• Rash
• Very fast heart rate (tachycardia). This is more likely to happen if you are taking more than two puffs twice daily.
• Feeling nervous.
Rare (affects less than 1 person in 1,000):
• Feeling dizzy
• Being unable to sleep or finding sleep difficult
• A reduction in the amount of potassium in your blood (you may get an uneven heartbeat, muscle weakness, cramp).
Very rare (affects less than 1 person in 10,000):
• Breathing difficulties or wheezing that gets worse straight after taking Serevent Evohaler. If this happens
stop using your Serevent Evohaler. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your
doctor straight away.
• Uneven heartbeat or your heart gives an extra beat (arrhythmias). If this happens do not stop using Serevent
Evohaler but tell your doctor.
• Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent
blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Sore mouth or throat
• Feeling sick (nausea)
• Aching, swollen joints or chest pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SEREVENT EVOHALER
• Keep out of the sight and reach of children.
• Straight after use, replace the mouthpiece cover firmly and click it into position. Do not use excessive force.
• Do not store above 30°C. Protect from direct sunlight and do not freeze.
• Do not pierce or burn container even when empty.
• Do not use Serevent Evohaler after the expiry date which is stated on the label and carton. The expiry date
refers to the last day of the month.
• If your inhaler fails to work properly or shows any signs of deterioration you should ask your doctor or
pharmacist for advice.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Serevent Evohaler contains
• Each puff provides 25 micrograms of the active ingredient salmeterol.
• There are 120 puffs in each canister.
• The other ingredient is norflurane (HFA 134a).
What Serevent Evohaler looks like and contents of the pack
Pressurised inhalation, suspension. The pressurised canister contains a white to off white suspension for inhalation.
PL No: 15814/0875
Serevent® Evohaler® 25 micrograms pressurised inhalation, suspension
POM
This product is manufactured by Glaxo Wellcome Production, 23 Rue Lavoisier, 27000 Evreux, France and is
procured from within the EU and repackaged by the Product Licence holder: OPD Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision and Issue date (Ref.): 12.03.2014
Serevent and Evohaler are trademarks of the GlaxoSmithKline group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.